Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

South Valley University

Status: Completed

Conditions: Acute Respiratory Failure Post Surgical (Diagnosis)

Treatments: Device: NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT04877353

NIV _COPD

Details and patient eligibility

About

In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria:

   • Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
   • Moderate to very severe COPD (GOLD II to IV).
   • ASA functional status II or greater.

2. Exclusion criteria:

   • Contraindications to the application of NIV.
   • Sleep apnea syndrome.
   • Facial deformation.
   • Inability to follow the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Group N

Experimental group

Description:

50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery

Treatment:

Device: NIV

group C

No Intervention group

Description:

50 patients recieved conventional oxygen therpy.